Improving Bowel Habits of Elderly With Probiotics and Non-probiotics
NCT ID: NCT02949882
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
260 participants
INTERVENTIONAL
2017-04-30
2017-08-31
Brief Summary
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Detailed Description
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A randomized, double-blind, superiority, multicentre trial. In this trial a probiotic fermented milk drink will be compared to a non-probiotic drink on its potential to improve bowel habits. Both drinks are commercially available in the supermarket. After a run-in period of 2 weeks, 260 subjects will be randomized (1:1) into either the probiotic fermented milk arm (n=130) or the non-probiotic drink arm (n=130), both for a period of 10 weeks.
The study population consists of 260 frail elderly of relatively high age (\>80 years old on average) living in several nursing homes in The Netherlands. One arm receives daily one bottle (65 ml) of Yakult Original (YOR), a probiotic fermented milk drink containing at least 6,5\*10\^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS), for 10 consecutive weeks without changing the regular diet. The other arm will receive a dairy milk drink (AH Basic Dairy Peach Drink, 65 mL) for 10 consecutive weeks, also without changing the regular diet.
The change in bowel habits of the subjects will be measured according to two main study parameters; (a) Stool-quality according to the 7-point Bristol stool chart, and (b) defecation frequency, measured as number of stools per time unit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic Intervention
130 Elderly participants receiving daily 65ml Yakult for 10 consecutive weeks.
Yakult
Containing at least 6,5\*10\^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
Non-Probiotic Intervention
130 Elderly participants receiving daily 65 ml of Dairy Peach Drink (AH Basic) for 10 consecutive weeks.
Dairy Peach Drink (AH Basic)
Commercially available dairy drink with peach flavour.
Interventions
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Yakult
Containing at least 6,5\*10\^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
Dairy Peach Drink (AH Basic)
Commercially available dairy drink with peach flavour.
Eligibility Criteria
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Inclusion Criteria
* Age of ≥ 70 year
Exclusion Criteria
* Immune deficient
* Intensive medication
* Life expectancy of ≤ 6 months
* Lactose intolerance
* Cow milk allergy - Stoma
* Major gastro-intestinal surgery in the past (e.g. bowel resection, gastric bypass)
* IBD
* Currently using a probiotic product, and not willing to stop this 4 weeks prior to the start of the study
70 Years
ALL
Yes
Sponsors
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Yakult Europe BV
INDUSTRY
Athena Institute, Netherlands
OTHER
Responsible Party
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Eric Claassen
Prof. Dr.
Principal Investigators
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Eric Claassen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Athena Institute, Free University of Amsterdam
Central Contacts
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Related Links
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Executive organisation (Clinical Research Rotterdam)
Other Identifiers
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14NL-1-TLM-CON2
Identifier Type: -
Identifier Source: org_study_id